AffyImmune Therapeutics

This morning, AffyImmune announced the appointment of Deyaa Adib, MD as Chief Medical Officer. In a statement, Affy CEO Dr. Daniel Janse said "Dr. Adib brings extensive experience in late-stage clinical development and regulatory engagement for AffyImmune to bring our therapeutic to patients. We look forward to Deyaa's contributions as a proven drug developer, business leader and researcher in our continued evolution toward becoming a commercial-stage biopharmaceutical company with a maturing clinical pipeline." For more information, see the comments for this morning's press release - and welcome to the Affy team, Deyaa!

AffyImmune Therapeutics Expands Board of Directors with Key Appointments Learn more & get our take ?? https://lnkd.in/giJvFsQZ “I am delighted to join AffyImmune’s Board and to work with the management team to bring industry-best CMC and supply chain practices, and ready AIC100 for registrational trials and commercial launch.” — Rick Rutter, Ph.D., Former Executive Vice President, Biotherapeutics Pharmaceutical Sciences at Pfizer; Expert Consultant “Joining AffyImmune’s Board of Directors is an exciting opportunity to contribute to the expansion of AIC100 beyond advanced thyroid cancers, into larger indications such as NSCLC.” — Jorge Nieva, M.D., Associate Professor of Clinical Medicine at?Keck School of Medicine of the University of Southern California #cancer #biotech #SoHCNews

AffyImmune Appoints Drs. Rick Rutter and Jorge Nieva to Board of Directors - https://lnkd.in/gyGCrvPs Follow #citybiz on LinkedIn - https://lnkd.in/eBgXKiz8 Post to citybiz - https://lnkd.in/eCbDHkxj Rick Rutter, Jorge Nieva, AffyImmune Therapeutics #biotechnology #boardofdirectors

We’re excited to announce the appointment of Rick Rutter, Ph.D., and Jorge Nieva, M.D., to our Board of Directors. The addition of these distinguished leaders in clinical development and manufacturing strengthens AffyImmune’s commitment to advancing its AIC100 program in advanced thyroid cancers and non-small cell lung cancer (NSCLC). “We are thrilled to welcome Rick and Jorge to our board at such an important time for AffyImmune, as we advance our CAR T cell product candidate AIC100 towards registrational studies for advanced thyroid cancers, and plan for our Phase 1 trial for non-small cell lung cancer,” said Daniel Janse, CEO, AffyImmune. “Their insight and counsel as members of our board will be invaluable as we validate a commercially robust CAR T cell manufacturing process and focus our NSCLC clinical strategy on patients that will receive the greatest benefit from AIC100.” Read the release: ???? https://lnkd.in/eDvVNE_m

Our CEO Daniel Janse is speaking on the funding biotech innovation and scaling up panel at LSX USA Congress today. Looking forward to connecting with everyone there.

Our CEO Daniel Janse will be speaking at the LSX USA Congress this Wednesday, Sept. 11, 11:00am?-?11:40am. Funding #Biotech Innovation and Scaling Up As operating models within biotech continue to evolve aided by new technologies and pressures to evolve, there is more pressure on biotech leaders to show investors and partners how they intend to scale up, deliver products to patients and prove value. The panel will be moderated by Kyle DiLella, Team Lead, Emerging Corporate Life Sciences at Citi. More information about the panel here: https://lnkd.in/eGgg9a2b

Pharmacy Times covers our recent ASCO data and RMAT designation: “We believe this important recognition from the FDA further supports the therapeutic potential of AIC100 to change the current treatment paradigm in advanced thyroid cancer and potentially other forms of aggressive solid tumors,” said Daniel Janse, PhD, CEO at AffyImmune, in a news release. “RMAT designation was granted following the FDA’s review of safety and efficacy data from the first 10 patients dosed with AIC100 in our phase 1 study. We believe the RMAT designation reinforces the potential ability of AIC100 to meet the high unmet medical need in recurrent ATC, an aggressive disease where a standard of care is currently not available.” Read the full article: https://lnkd.in/e7CFKhHT

RegMedNet covers our recent RMAT designation: CAR-T therapy for thyroid cancer gets RMAT designation The FDA has granted RMAT designation to AffyImmune’s (MA, USA) CAR T-cell therapy candidate, AIC100, for the treatment of recurrent anaplastic thyroid cancer. AIC100 leverages lymphocyte function-associated antigen 1 on the surface of the CAR-T cells to target and bind intercellular adhesion molecule 1 on the surface of cancer cells. Read the article: https://lnkd.in/eJZ-XHp3

?????? ???????? & ???????? ?????????????? ????????: ???????? ???????? ??????????????? ?? Pfizer announced that the European Commission has granted conditional marketing authorization for DURVEQTIX?, a gene therapy for the treatment of severe and moderately severe hemophilia B (congenital factor IX deficiency) in adult patients without a history of factor IX inhibitors and without detectable antibodies to variant AAV serotype Rh74. DURVEQTIX is designed to enable people living with hemophilia B to produce factor IX (FIX) themselves via a one-time dose, rather than multiple intravenous FIX infusions weekly or biweekly with the current standard of care. ?? Sangamo Therapeutics, Inc. reported that Pfizer’s Phase 3 AFFINE trial for giroctocogene fitelparvovec, a hemophilia A gene therapy, met primary and key secondary objectives, showing superiority to standard prophylaxis. The trial demonstrated significant reductions in annualized bleeding rates and a high percentage of participants maintaining effective FVIII activity. Giroctocogene fitelparvovec was generally well-tolerated. Sangamo could earn up to $220 million in milestone payments and royalties if the therapy is commercialized. ?? AffyImmune Therapeutics announced that they have received Regenerative Medicine Advanced Therapy (RMAT) Designation from the FDA for its CAR T-cell product candidate, AIC100, as a potential treatment for patients with recurrent anaplastic thyroid cancer, the most aggressive form of the disease. ?? Oxford Nanopore Technologies and Plasmidsaurus announced a multi-year collaboration to enhance plasmid sequencing using nanopore technology. This partnership aims to set new standards for quality and speed in plasmid sequencing, overcoming limitations of traditional methods. The collaboration will also focus on co-developing new technologies and applications for microbial and gene therapy. ?? Ocugen, announced the completion of dosing in the third cohort of its Phase 1/2 ArMaDa trial for OCU410, a gene therapy for geographic atrophy (GA), an advanced dry age-related macular degeneration. Current FDA-approved GA treatments offer limited benefits and require continuous injections. OCU410, potentially a transformative one-time treatment, showed promise in three subjects receiving the highest dose. The Phase 2 trial will now evaluate safety and efficacy in a larger group. ?? BioCardia, Inc. announced that the confirmatory Phase 3 trial of its autologous?CardiAMP?cell therapy product candidate for patients with ischemic heart failure of reduced ejection fraction has commenced enrollment in the US. Granted Breakthrough Designation by the FDA, the CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. ?? My aim is to be the messenger when it comes to your CGT news. Follow #mCGT to stay updated! #celltherapy #genetherapy #ATMP

Cancer Network covers our recent RMAT designation for our CAR T therapy candidate in #thyroid cancer. Read the article: https://lnkd.in/ezfCNPSc